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A Phase III Double-Blind Trial for Surgically Resected Early Stage Non-small Cell Lung Cancer: Crizotinib Versus Placebo for Patients With Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion Protein
Overall Recruitment Status: Active, currently enrolling
 
Official Title
A Phase III Double-Blind Trial for Surgically Resected Early Stage Non-small Cell Lung Cancer: Crizotinib Versus Placebo for Patients With Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion Protein
 
Region Sponsors
California - Northern
Eastern Cooperative Oncology Group
 
Acronym KP IRB No.
CN-15-2261-C
 
Study Type Phase
Clinical Trial Phase III
 
Study Population Description
Individuals with Stage IB, IIA, IIB, IIIA Non-small Cell Lung Cancer
 
Purpose
This randomized phase III trial studies how well crizotinib works and compares it to placebo in treating patients with stage IB-IIIA non-small cell lung cancer that has been removed by surgery and has a mutation in a protein called ALK. Mutations, or changes, in ALK can make it very active and important for tumor cell growth and progression. Tumors with this mutation may respond to treatments that target the mutation, such as crizotinib. Crizotinib may stop the growth of tumor cells by blocking the ALK protein from working. It is not yet known if crizotinib may be an effective treatment for treating non-small cell lung cancer with an ALK fusion mutation.
 
Detailed Description
 
Gender Age Limit
Male & Female
 
Inclusion Criteria
  • Patients must have undergone complete surgical resection of their stage IB (>= 4 cm), II, or IIIA NSCLC per American Joint Committee on Cancer (AJCC) 7th edition and have had negative margins
  • Baseline chest computed tomography (CT) must be performed within 3 months (90 days) prior to randomization to ensure no evidence of disease. If clinically indicated additional imaging studies must be performed to rule out metastatic disease
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Patients must be registered to the ALCHEMIST-SCREEN (ALLIANCE A151216) trial prior to randomization
  • Positive for translocation or inversion events involving the ALK gene locus (e.g. resulting in echinoderm microtubule associated protein like 4 [EML4]-ALK fusion) as determined by the Vysis Break Point fluorescence in situ hybridization (FISH) assay and defined by an increase in the distance between 5' and 3' ALK probes or the loss of the 5' probe. This must have been performed: *By a local Clinical Laboratory Improvement Amendments (CLIA) certified laboratory: Report must indicate the results as well as the CLIA number of the laboratory which performed the assay. Tissue must be available for submission for central, retrospective confirmation of the ALK fusion status via ALCHEMIST-SCREEN (ALLIANCE A151216) OR *Patient registered to and the ALK fusion status performed centrally on the ALCHEMIST-SCREEN (ALLIANCE A151216)
  • Women of childbearing potential and sexually active males must be strongly advised to practice abstinence or use an accepted and effective method of contraception
 
Exclusion Criteria
  • N3 disease is not allowed
  • Women must not be pregnant or breast-feeding
  • Patients must NOT have uncontrolled intercurrent illness including, but not limited to, serious ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • No known interstitial fibrosis or interstitial lung disease
  • No prior treatment with crizotinib or another ALK inhibitor
  • No ongoing cardiac dysrhythmias of grade >= 2 National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, uncontrolled atrial fibrillation (any grade), or corrected QT (QTc) interval > 470 msec
  • No use of medications, herbals, or foods that are known potent cytochrome P450, subfamily 3A, polypeptide 4 (CYP3A4) inhibitors or inducers, included but not limited to those outlined

 
Keywords and/or Specific Medical Conditions
  • Respiratory Tract Neoplasms
  • Molecular Mechanisms of Pharmacological Action
  • Bronchial Neoplasms
  • Neoplasms
  • Carcinoma, Bronchogenic
  • Neoplasms by Site
  • Carcinoma, Non-Small-Cell Lung
  • Pharmacologic Actions
  • Crizotinib
  • Protein Kinase Inhibitors
  • Enzyme Inhibitors
  • Respiratory Tract Diseases
  • Lung Diseases
  • Thoracic Neoplasms
  • Lung Neoplasms
  • Oncology (Adult)
 
KP Clinical Facility
  • Central Valley-Modesto
  • Central Valley-Stockton
  • Diablo Medical Center-Antioch
  • Diablo Medical Center-Deer Valley
  • Diablo Medical Center-Walnut Creek
  • Fremont Medical Center
  • Fresno Medical Center
  • Hayward Medical Center
  • Oakland Medical Center
  • Redwood City Medical Center
  • Richmond Medical Center
  • Roseville Medical Center
  • Roseville Medical Center-Rancho Cordova
  • Sacramento Medical Center
  • San Francisco Medical Center
  • Santa Clara Medical Center-Homestead
  • South Sacramento Medical Center
  • South San Francisco Medical Center
  • Vallejo Medical Center
  • Vallejo Medical Center-Vacaville
 
Clinical Area
  • Oncology (Adult)


Principal Investigator:
Louis Fehrenbacher, MD
Contact Information:
- Desiree Goldstein
-desiree.goldstein@kp.org
-Vallejo Medical Center


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